Almac Sciences: “First in Man” Approach to Peptides
News Dec 14, 2007
Almac Sciences has this year announced details of its “First in Man” approach to peptide synthesis. This embraces and offers development of peptide synthesis, full analytical support (including method development and validation, reference standard, QA release and stability studies); GMP batches for Phase I and II (scaling from grammes to several kgs.), and finally support with CMC documentation.
It also stresses the strong connectivity between its cGMP peptide offering and other specialist capabilities within Almac Sciences – including 14C radiolabelling, cytotoxic conjugation and sterile formulation and filling.
Almac Sciences claims that it has capability to produce hundreds of peptides per month under contract peptide antigen synthesis, with conjugation to carrier protein if required. Bespoke custom work can typically include mgs to low gs, with cGMP at low kgs. The product listing includes natural/modified chemokines, with a specialization in long chain peptide synthesis. API production capacity is up to 100s g/batch.
Chemical synthesis capability:
In development of site-specific chemical modification of proteins, chemical synthesis production of peptides and proteins has proved especially powerful. It enables numerous side-chain and backbone site-specific modifications to be incorporated into the primary sequence - providing a route for producing the increasingly sophisticated peptides required by the bio-community.
Almac Sciences has successfully developed a suite of both native and site-specifically modified chemokines. These have broad applications across research and drug discovery and are integral to methods employed by pharma and biotech to accelerate drug discovery.
Combining improved solid-phase synthetic methodology for step-wise chain assembly, complementary purification (including novel ‘tag’-based methods) peptides can be synthesized in high yield.
Almac Sciences has strong connectivity between its cGMP peptide offerings and other in-house niche capabilities. These include 14C radiolabelling, with several complex peptide and radiolabelling projects completed, together with cytotoxic conjugations to peptides, and sterile formulation and finishing.
Sterile formulation and filling is through partnership in the US with with Coldstream Laboratories, Lexington, Kentucky. This provides IV formulation and sterile fill of cytotoxics and potents for clinical trial applications through its innovative sterile manufacturing facility at the Research Campus, near Lexington.
Working with Coldstream completes Almac Sciences’ supply chain solutions package in cytotoxics and potents, for which it already has significant in-house process research, development, manufacturing and logistics capability at its Craigavon, Northern Ireland complex.
Part of the Almac Group, Almac Sciences is distinct for its capability to make very long peptides (60 – 100 mer) to GMP. The company’s main facility is its 80,000 sq. ft., £25m
Peptide Service offering:
Services include Clinical grade peptide supply, conforming to GMP ICHQ7A, with supporting development/documentation, with analytical packages and a stability package to support IND. Production is focused through a scale up GMP lab and small scale GMP lab, employing solid phase peptide Synthesis Technology, Fmoc chemistry for long peptides and in-process UV monitoring of coupling and de-protection.
In Purification Technology, RP-HPLC is employed for initial peptide purification, with API purity tailored to customer requirements (High Purity API 95 -99.9%). Isolation is via Lyophilization in class 100,000 clean room, with Class 100,000 and 10,000 facilities for freeze drying of API and packaging in a class 10,000 environment.
Scale up and optimization strategy is focused on developing/optimizing all areas of the total process, with emphasis (eg) on purification and freeze drying time to enhance throughput and serve the cost-of-goods agenda.